Immune-related hepatitis1


  • YERVOY™ is associated with serious immune-related hepatotoxicity. Fatal hepatic failure has been reported in clinical trials
  • Monitor liver function tests (LFTs), (hepatic transaminase and bilirubin levels) and assess for signs and symptoms of hepatitis before each dose of YERVOY™
  • Withhold YERVOY™ dosing in patients with moderate aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevations of >5 to ≤8 times upper limit of normal (ULN), or moderate total bilirubin elevation of >3 to ≤5 times ULN
  • Permanently discontinue YERVOY™ for any of the following:
    – Severe AST or ALT elevations of >8 times ULN
    – Total bilirubin elevations of > 5 times ULN
    – Symptoms of hepatotoxicity.
  • Systemic high-dose corticosteroids may be required.



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1. YERVOY™ Summary of Product Characteristics.

Senast uppdaterad:  2015-07-02Ansvarig:  Anna Labecker